The Effects of Reducing Prolonged Sitting Bouts With Regular Light Upright Movement Breaks on Glucose Regulation in Individuals at High Risk of or With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Glucose incremental Area Under the Curve (iAUC)
研究概览
简要总结
Over 3 million in the United Kingdom are now diagnosed with type 2 diabetes, with current estimates suggesting this will rise to over 5 million by 2025. Type 2 diabetes increases the risk of developing cardiovascular disease, kidney disease, depression, neuropathy and dementia, along with being a leading cause of amputation and adult blindness.
Sedentary behaviour, defined as any waking moment spend sitting or reclining with energy expenditure equal to or less than 1.5 METs, has emerged as a risk factor in the development of type 2 diabetes. Recent evidence has shown that breaking up prolonged sitting with regular short bouts of activity or standing lower postprandial glucose and insulin. However, the effectiveness of breaking prolonged sitting on glucose metabolism over a longer period of time is unknown. Therefore, the aim of this study is to investigate whether the reduction in postprandial plasma glucose in response to breaking prolonged sitting time is maintained following an intervention to reduce and break up prolonged sitting over a four to five week period.
The study will be a single group intervention with pre and post randomised measurement conditions (prolonged sitting and light upright breaks) at both time points. A sample of 43 people (34 to complete), aged 50-75, identified as at risk of or with (drug naive) type 2 diabetes will be sought. The intervention will last approximately 5 weeks. Experimental conditions will be conducted before and after the intervention to assess whether reducing and breaking up prolonged sitting in free living effects glucose metabolism.
详细描述
Study Design
This study consists of an intervention lasting approximately 5 weeks (depending on follow-up measurement timings), with a before and after 'two-arm' randomised crossover design, one prior to the intervention and one at the end of the intervention used as measurement periods. Screening will require one laboratory visit, with the study commencing one week following baseline. The intervention will last a minimum of four weeks, while the measurement conditions will each involve two laboratory days separated by a minimum of five days. The duration from screening through to study end will be an estimated 9 weeks. This trial will evaluate the effectiveness of regular light upright movement breaks at reducing glucose iAUC by examining if acute adaptations to sitting time are maintained or improved following the behavioural intervention.
Study Setting
The study will be co-ordinated within the Leicester Biomedical Research Centre (Leicester Diabetes Centre) at the Leicester General Hospital. Clinical measurement sessions will be carried out by the appointed research team. Participants will be asked to visit the study centre on seven occasions.
Measurement conditions
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and Postmenopausal Females.
- •≥ 40 to ≤ 75 years of age.
- •And either:
- •Overweight (White: BMI > 25 - <30, South Asian, Black or Chinese: > 23 <27.5) with HbA1c between 6.0 and 7.5%, within the previous 36 months).
- •Obese (White: BMI ≥ 30, South Asian, Black or Chinese: ≥ 27.5).
- •Large proportions of their day spent sitting (self-reported).
- •Participant is willing and able to give informed consent to take part in the study.
- •Not planning on altering their diet during the study.
- •Able to walk without the use of an assistive device or requiring assistance form another person
排除标准
- •The participant may not enter the study if ANY of the following apply:
- •Reporting taking part in regular (at least once a week) sport of strenuous exercise.
- •HbA1c > 7.5%.
- •Overweight with HbA1c < 6.0%.
- •Taking any glucose lowering therapies.
- •Type 1 diabetes.
- •Recent cardiovascular event (within the last 12 months).
- •Female premenopausal.
- •Current smoker.
- •Terminal illness.
- •Steroid use.
- •Comorbidity that the research team consider to be a contraindication to involvement in the study
- •Unable to communicate in English.
- •Unable to provide written informed consent.
- •In the circumstance that an individual is not sure whether they meet the inclusion/ exclusion criteria, they will be reviewed by a named medic on the delegation of authority log for a clinical decision to be made during the baseline visit.
结局指标
主要结局
Glucose incremental Area Under the Curve (iAUC)
时间窗: Assessed via 10 blood samples.Two of which will be taken while fasting and the remainder taken at 30, 60, 120 and 180 minutes following both breakfast and lunch meals. This will be assessed for all of the 7.5 hour experimental treatment conditions
Glucose iAUC will be used to assess whether, following the intervention, the expected improvement in glucose metabolism is maintained or improved in the post-measurement conditions compared to the pre-measurement conditions.
次要结局
- Insulin incremental Area Under the Curve (iAUC)(Assessed via 10 blood samples.Two of which will be taken while fasting and the remainder taken at 30, 60, 120 and 180 minutes following both breakfast and lunch meals. This will be assessed for all of the 7.5 hour experimental treatment conditions)
- Triglycerides incremental Area Under the Curve (iAUC)(Assessed via 10 blood samples.Two of which will be taken while fasting and the remainder taken at 30, 60, 120 and 180 minutes following both breakfast and lunch meals. This will be assessed for all of the 7.5 hour experimental treatment conditions)
- Blood pressure incremental Area Under the Curve (iAUC)(Assessed prior to all 10 blood samples. This will be assessed for all of the 7.5 hour experimental treatment conditions)
- Acylated ghrelin(Assessed via 5 blood samples, One of which is taken fasted and the remainder taken at 30, 60, 120 and 180 minutes following breakfast during condition A)
- Total PYY(Assessed via 5 blood samples, One of which is taken fasted and the remainder taken at 30, 60, 120 and 180 minutes following breakfast during condition A)
- Subjective appetite - Hunger(Assessed after each blood sample during every experimental condition. Through study completion, an average of 9 weeks.)
- Subjective appetite - Fullness(Assessed after each blood sample during every experimental condition. Through study completion, an average of 9 weeks.)
- Subjective appetite - Satiety(Assessed after each blood sample during every experimental condition. Through study completion, an average of 9 weeks.)
- Fasting triglycerides(Before and after the intervention. Through study completion, an average of 9 weeks.)
- Fasting IL-6(Before and after the intervention. Through study completion, an average of 9 weeks.)
- Cholesterol(Before and after the intervention. Through study completion, an average of 9 weeks.)
- HDL Cholesterol(Before and after the intervention. Through study completion, an average of 9 weeks.)
- LDL Cholesterol(Before and after the intervention. Through study completion, an average of 9 weeks.)
- Fasting creatinine(Before and after the intervention. Through study completion, an average of 9 weeks.)
- Mood(Baseline and last week of the intervention. Through study completion, an average of 9 weeks.)
- Subjective appetite - Quantity(Assessed after each blood sample during every experimental condition. Through study completion, an average of 9 weeks.)
- Fatigue (acute)(Assessed after each blood sample during every experimental condition. Through study completion, an average of 9 weeks.)
- Energy (acute)(Assessed after each blood sample during every experimental condition. Through study completion, an average of 9 weeks.)
- Fasting glucose(Before and after the intervention. Through study completion, an average of 9 weeks.)
- Fasting insulin(Before and after the intervention. Through study completion, an average of 9 weeks.)
- Depressive symptoms(Baseline and last week of the intervention. Through study completion, an average of 9 weeks.)
- Chronic fatigue(Baseline and last week of the intervention. Through study completion, an average of 9 weeks.)
- Average blood glucose(Week following baseline and during the last week of the intervention. Through study completion, an average of 9 weeks.)
- Time spent in hypoglycemia(Week following baseline and during the last week of the intervention. Through study completion, an average of 9 weeks.)
- Time spent in hyperglycemia(Week following baseline and during the last week of the intervention. Through study completion, an average of 9 weeks.)
- Physical function(Baseline and at the end of the intervention. Through study completion, an average of 9 weeks.)
- Adherence to the intervention(Data during the intervention period will be compared to baseline. Through study completion, an average of 9 weeks.)
- Physical behaviours(Data during the intervention period will be compared to baseline. Through study completion, an average of 9 weeks.)
- Sedentary time(Data during the intervention period will be compared to baseline. Through study completion, an average of 9 weeks.)
- Light intensity physical activity(Data during the intervention period will be compared to baseline. Through study completion, an average of 9 weeks.)
- Moderate to vigorous intensity physical activity (MVPA)(Data during the intervention period will be compared to baseline. Through study completion, an average of 9 weeks.)
- Sleep(Data during the intervention period will be compared to baseline. Through study completion, an average of 9 weeks.)
- Intervention perception(Conducted at the end of the intervention. Through study completion, an average of 9 weeks.)